Outlook Therapeutics wins FDA appeal for eye drug application

Outlook Therapeutics Inc. (NASDAQ: OTLK) announced that the U.S. Food and Drug Administration has granted its appeal following a formal dispute resolution process for ONS-5010/LYTENAVA (bevacizumab-vikg). The company plans to resubmit its biologics license application to the FDA in June 2026.

The FDA's Office of New Drugs concluded that substantial evidence of effectiveness has been established for LYTENAVA for treating neovascular age-related macular degeneration. The determination was based on results from the NORSE TWO trial, along with confirmatory evidence including NORSE EIGHT, natural history data, and mechanistic and pharmacodynamic data.

The company initiated the formal dispute resolution process after receiving a complete response letter on December 30, 2025, regarding its biologics license application for ONS-5010/LYTENAVA. The FDA response directs the Division of Ophthalmology and Office of Specialty Medicine to work with Outlook Therapeutics on final labeling.

The resubmission is expected to be classified as a Class 1 resubmission with a PDUFA date and decision anticipated within 60 days of the FDA's receipt. If approved, ONS-5010/LYTENAVA would be the first FDA-approved ophthalmic formulation of bevacizumab with an FDA-approved manufacturing process and labeling.

"The Agency's action on our appeal provides a clear path forward toward U.S. approval," said Bob Jahr, chief executive officer of Outlook Therapeutics.

LYTENAVA has already received marketing authorization from the European Commission and the UK's Medicines and Healthcare products Regulatory Agency for treating wet age-related macular degeneration. Outlook Therapeutics has commenced commercial launch in Germany, Austria, and the UK.

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